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INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

INTEGRADWeb MPR/MIP ™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb MPR/MIP ™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.

This document is a 510(k) Summary of Safety and Effectiveness for the INTEGRADWeb MPR/MIP™ system by Dynamic Imaging, Inc., submitted to the FDA in 2004. It focuses on declaring substantial equivalence to a predicate device, rather than presenting a study for acceptance criteria.

Therefore, much of the requested information, such as acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and details on standalone or MRMC studies, is not available in the provided text. The document is primarily a regulatory submission for market clearance.

However, based on the information provided, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that the submission "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This indicates a qualitative comparison rather than a quantitative performance evaluation against pre-defined metrics within the document.

2. Sample Size Used for the Test Set and Data Provenance

Not available. The document does not describe a "test set" in the context of evaluating the device's performance against specific metrics. It indicates the device handles various medical images from different modalities (CT, MR, US, NM, CR, DR, DX, XA, PT), but no details on specific image datasets used for a performance study are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not available. As no specific performance study with a "test set" is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not available. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's functionality as a Picture Archiving Communications System (PACS) and its substantial equivalence to a predicate device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. The document describes the INTEGRADWeb MPR/MIP™ as a software system for image management, processing, and display within a PACS environment, not as an AI algorithm providing diagnostic interpretations. Therefore, a standalone algorithm performance study is not relevant to the described device. The device "does not produce any original medical images" and "a physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The Type of Ground Truth Used

Not applicable/Not available. As no specific performance study that required ground truth for evaluation is described, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not available. The device is a PACS, not a machine learning model that would require a dedicated training set in the typical sense. Its functionality revolves around accepting, transferring, displaying, storing, and digitally processing existing medical images.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available. As there's no mention of a training set for a machine learning model, this information is not provided.

In summary, the provided document is a regulatory submission for a PACS device, attesting to its safety and substantial equivalence based on its functionalities and adherence to standards, rather than a detailed report of a clinical performance study with acceptance criteria.

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INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.

INTEGRADWeb™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.

The provided text is a 510(k) summary for INTEGRADWeb™ by Dynamic Imaging, Inc., a Picture Archiving Communications System. Based on the document, this device is a software system for managing and displaying medical images. It does not produce original medical images, nor does it make any diagnostic interpretations or claims about medical performance. As such, the document does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/CADe devices that perform image analysis or diagnostic aid.

Here's why the direct questions cannot be answered from the provided text:

• The device is a PACS system, primarily for image management, storage, communication, and display. It explicitly states, "The system does not produce any original medical images." and "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This indicates that the device supports human interpretation rather than performing automated diagnostic tasks.
• The 510(k) application focuses on demonstrating "substantial equivalence" to a predicate PACS device (ISITE RADIOLOGY) by highlighting technological characteristics, indications for use, and a hazard analysis. It does not involve a performance study against a ground truth for diagnostic accuracy, sensitivity, or specificity.

Therefore, the following points are not applicable or cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: Not applicable, as there are no diagnostic performance metrics for this type of device.
2. Sample sized used for the test set and the data provenance: Not applicable. No diagnostic test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for diagnostic performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic aid device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a system for image management, not autonomous algorithmic performance.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no mention of an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document pertains to a Picture Archiving Communications System (PACS) that facilitates the handling and viewing of medical images, rather than performing automated analysis or diagnosis. Consequently, the performance criteria and study details requested are not relevant or present within this type of regulatory submission for this specific device. The 'study' mentioned is a hazard analysis and a comparison to a predicate device for substantial equivalence, not a clinical performance study.

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